Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 273-606-8 | CAS number: 68990-52-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 49.3 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Modified dose descriptor starting point:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- (Default (DNEL calculator))
- AF for differences in duration of exposure:
- 2
- Justification:
- (Default (DNEL calculator))
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- (Default (DNEL calculator))
- AF for other interspecies differences:
- 2.5
- Justification:
- (Default (DNEL calculator))
- AF for intraspecies differences:
- 5
- Justification:
- (Default (DNEL calculator))
- AF for the quality of the whole database:
- 1
- Justification:
- (Default (DNEL calculator))
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Modified dose descriptor starting point:
- NOAEL
- AF for dose response relationship:
- 1
- Justification:
- (Default (DNEL calculator))
- AF for differences in duration of exposure:
- 2
- Justification:
- (Default (DNEL calculator))
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- (Default (DNEL calculator))
- AF for other interspecies differences:
- 2.5
- Justification:
- (Default (DNEL calculator))
- AF for intraspecies differences:
- 5
- Justification:
- (Default (DNEL calculator))
- AF for the quality of the whole database:
- 1
- Justification:
- (Default (DNEL calculator))
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Read across statement for toxicological and ecotoxicological endpoints
Depending on the raw material source (in nature occurring natural oils and fats) Fatty acid methyl esters can vary in their chain length distribution. Such products are typical UVCB substances. Nevertheless the toxicological and ecotoxicological profile derive from the individual components within the UVCB. In order to avoid extensive testing and duplication of animal tests the industry took the approach to test a representative Fatty acid methyl ester, Fatty acid, C16-C18 and C18-unsatd., me esters (EC 267-015-4; CAS 67762-38-3), with a broad chain length distribution and read across the test results to Fatty acids, vegetable-oil, Me esters (EC 273-606-8; CAS 68990-52-3).
___________________________________________________________________________________________
Acute toxicity
The guidance on dose/concentration response regarding human health (section R8.1.2.5 of chapter R.8 of the Guidance on Information Requirements and Chemical Safety Assessment) indicates that acute DNELs do not need to be calculated for substances that are not classified for an acute toxicity hazard. As this substance is not classified for acute toxicity hazards, no acute DNELs need to be calculated.
Local effects
Since no local effects were described, the DNELs are based on the systemic effects only.
LONG -TERM DNEL
The long-term DNEL is based on the most critical NOAEL seen in the repeated/ reproduction study with a NOAEL of 1000 mg/kg.
long-term DNEL for the inhalation route (systemic effects, route to-route extrapolation) =
1000 * (1/ sRV(a) * 0.67 (b) )
--------------------------------------------------------------------------------------------------------------------------- =
25(c)
1000* (1/ 0.384) * 0.67
-------------------------------------------------------- = .6.96mg/m3
25
(a) Standard respiratory volume (sRV) rat:0.384 m3/kg
(b) correction for worker respiratory volume (conservative default for route to route)
(c)interspecies (without allometric scaling) * intraspecies * correction for duration: (2.5 * 5 * 2 )
long-term DNEL for the dermal route (systemic effects, route to-route extrapolation)
1000 *1 (a) / 4*2.5*5 (b) *2 (c) = 10mg/kg bw/day
(a) route to route extrapolation oral to dermal
(b) assessment factors (interspecies * intraspecies (4*2.5) * 5)
(c) Correction for duration from subacute to chronic (2)
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Modified dose descriptor starting point:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- (Default (DNEL calculator))
- AF for differences in duration of exposure:
- 2
- Justification:
- (Default (DNEL calculator))
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- (Default (DNEL calculator))
- AF for other interspecies differences:
- 2.5
- Justification:
- (Default (DNEL calculator))
- AF for intraspecies differences:
- 10
- Justification:
- (Default (DNEL calculator))
- AF for the quality of the whole database:
- 1
- Justification:
- (Default (DNEL calculator))
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The guidance on dose/concentration response regarding human health (section R8.1.2.5 of chapter R.8 of the Guidance on Information Requirements and Chemical Safety Assessment) indicates that acute DNELs do not need to be calculated for substances that are not classified for an acute toxicity hazard. As this substance is not classified for acute toxicity hazards, no acute DNELs need to be calculated.
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Modified dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
long-term DNEL for the dermal route (systemic effects, route to-route extrapolation)
1000 *1 (a) / 4*2.5*5 (b) *2 (c) = 5.01mg/kg bw/day
(a) route to route extrapolation oral to dermal
(b) assessment factors (interspecies * intraspecies (4*2.5) * 10)
(c) Correction for duration from subchronic to chronic (2)
- AF for dose response relationship:
- 1
- Justification:
- (Default (DNEL calculator))
- AF for differences in duration of exposure:
- 2
- Justification:
- (Default (DNEL calculator))
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- (Default (DNEL calculator))
- AF for other interspecies differences:
- 2.5
- Justification:
- (Default (DNEL calculator))
- AF for intraspecies differences:
- 10
- Justification:
- (Default (DNEL calculator))
- AF for the quality of the whole database:
- 1
- Justification:
- (Default (DNEL calculator))
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Modified dose descriptor starting point:
- NOAEL
- AF for dose response relationship:
- 1
- Justification:
- (Default (DNEL calculator))
- AF for differences in duration of exposure:
- 2
- Justification:
- (Default (DNEL calculator))
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- (Default (DNEL calculator))
- AF for other interspecies differences:
- 2.5
- Justification:
- (Default (DNEL calculator))
- AF for intraspecies differences:
- 10
- Justification:
- (Default (DNEL calculator))
- AF for the quality of the whole database:
- 1
- Justification:
- (Default (DNEL calculator))
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Acute toxicity
The guidance on dose/concentration response regarding human health (section R8.1.2.5 of chapter R.8 of the Guidance on Information Requirements and Chemical Safety Assessment) indicates that acute DNELs do not need to be calculated for substances that are not classified for an acute toxicity hazard. As this substance is not classified for acute toxicity hazards, no acute DNELs need to be calculated.
Local effects
Since no local effects were described, the DNELs are based on the systemic effects only.
LONG -TERM DNEL
The long-term DNEL is based on the most critical NOAEL seen in the repeated/ reproduction studywith a NOAEL of 1000 mg/kg.
long-term DNEL for the inhalation route (systemic effects, route to-route extrapolation) =
1000 * (1/ sRV(a))
--------------------------------------------------------------------------------------------------------------------------- =
2.5*10*2 (b)
1000* (1/ 1.15)
-------------------------------------------------------- = 23 mg /m3
50
(a) Standard respiratory volume (sRV) rat for general public (24h):1.15 m3/kg
(b) Interspecies (without allometric scaling) * intraspecies * correction for duration: (2.5 * 10 * 2 )
long-term DNEL for the dermal route (systemic effects, route to-route extrapolation)
1000 *1 (a) / 4*2.5*5 (b) *2 (c) = 5.01 mg/kg bw/day
(a) route to route extrapolation oral to dermal
(b) assessment factors (interspecies * intraspecies (4*2.5) * 10)
(c) Correction for duration from subchronic to chronic (2)
long-term DNEL for the oral route (systemic effects)
1000 / 4*2.5*5 (a) *2(b) = 5.01 mg/kg bw/day
(a) assessment factors (interspecies * intraspecies (4*2.5) * 10)
(b) Correction for duration from subchronic to chronic (2)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
